Z-1841-2016 Class II Terminated
FDA device recall Z-1841-2016 was initiated by Integra York PA, Inc on March 11, 2016 and is designated Class II. Reason for recall: One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle. The recall status is terminated (terminated April 17, 2017). Affected quantity: 678 Chisel Blade Holders.
Recall Details
- Product Type
- Devices
- Report Date
- June 8, 2016
- Initiation Date
- March 11, 2016
- Termination Date
- April 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 678 Chisel Blade Holders
Product Description
Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
Reason for Recall
One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.
Distribution Pattern
Worldwide distribution. US nationwide, Mexico, and Korea.
Code Information
Catalogue No. 4-405, Lot # 97327